PRODUCT DETAIL
SPECIMEN COLLECTION AND STORAGE
Whole Blood Specimens
1. Clean the area to be lanced with alcohol prep pad.
2. Squeeze the fingertip and pierce it with the sterile lancet.
3. Wipe away the first drop of blood with sterile gauze or cotton.
4. Using a disposable pipette, collect blood from the puncture site.The whole blood may be used for testing immediately or may be refrigerated at 2-8℃ up to three days. Specimens that have been refrigerated must be brought and equilibrated to room tempera ture prior to testing.
Serum or plasma Specimens
1. Centrifuge whole blood to get plasma or serum specimen.
2. If serum is not tested immediately, it should be refrigerated at 2-8℃. For storage period greater than three days, freezing is recommended. Such specimen should be brought and equilibrated to room temperature prior to use.
3. Serum containing precipitate may yield inconsistent test results. Such specimens must be clarified prior to assaying.
TEST PROCEDURE
1. Bring the pouched test device to room temperature (15-30℃) prior to testing. Do not open the pouch until ready to perform theassay.
2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.
3. Dengue IgG / IgM： Use the pipette to draw and slowly add 1 drop of whole blood、serum、plasma to the sample well.Hold the buffer bottle vertically and add 1 drop to the sample well.
4. Dengue Ns1 Ag：Use the pipette to draw and slowly add 2 drops of whole blood、serum、plasma to the sample well.Hold the buffer bottle vertically and add 1 drop to the sample well.
5. Read test results between 15-20 minutes. Do not interpret results after 20 minutes.
Caution: The above interpreting time is based on room temperature range of 15 - 30°C. If your room temperature is significantly lower than 15 °C, then the interpreting time should be properly increased to 30 minutes.
INTERPRETATION OF RESULTS
Dengue IgG & IgM：
Dengue Ns1 Ag：
PERFORMANCE CHARACTERISTICS
IgG/IgM：
Sensitivity and Specificity
A clinical study using a total 154 serum specimens was conducted at various sites in 4 countries. The results of the Dengue IgG / IgM Rapid Test were compared with a commercially available ELISA test.The sensitivity and specificity of the IgG and IgM test results are
Accuracy of 98%（151/154）based on internal Quality Control Standards.
NS1:
Sensitivity and Specificity
A clinical study using a total 309 specimens was conducted. The results of the Dengue NS1 Ag test were compared with SD commercially available ELISA test. The sensitivity and specificity results are given as below:
In a comparison of the Dengue NS1 Ag test with SD ELISA, results gave a sensitivity of 96.3% (78/81), a specificity of 97% (194/200) and a total agreement of 96.8% (272/281).
